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avinash ★ India, 2022-07-06 09:04 (820 d 12:04 ago) Posting: # 23108 Views: 2,646 |
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Dear Members This is with regard to ICH M10 guideline For Matrix effect, it is mentioned as “should be evaluated by analysing at least 3 replicates of low and high QCs, each prepared using matrix from at least 6 different sources/lots. For each individual matrix sources/lots evaluated, the accuracy should be within ±15% of the nominal concentration and the precision (per cent coefficient of variation (%CV)) should not be greater than 15%” To comply with M10 guideline, for checking accuracy is it necessary to have calibration standards in matrix factor experiment? Matrix factor, Our practice is to compare post extracted spiked sample vs aqueous sample, acceptance criteria is CV for matrix factor and IS normalised matrix factor should be ≤ 15% Please opine. Thanks & regards, Avinash Edit: category changed [Ohlbe] |
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Ohlbe ★★★ France, 2022-07-06 12:18 (820 d 08:50 ago) @ avinash Posting: # 23109 Views: 2,156 |
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Dear Avinash, ❝ For each individual matrix sources/lots evaluated, the accuracy should be within ±15% of the nominal concentration and the precision (per cent coefficient of variation (%CV)) should not be greater than 15%” ❝ ❝ To comply with M10 guideline, for checking accuracy is it necessary to have calibration standards in matrix factor experiment? Well, how else could you check accuracy ? But of course: the blank matrix used to prepare calibration samples should not be one of the matrices tested for matrix effects, otherwise this would bias the experiment (you'd be sure that at least this one would pass). ❝ Matrix factor, Our practice is to compare post extracted spiked sample vs aqueous sample, acceptance criteria is CV for matrix factor and IS normalised matrix factor should be ≤ 15% Yes, that's what was in the EMA guideline, based on the recommendations of the Crystal City III conference in 2006. Recommendations in M10 are now different and you'll have to update your SOP and change your practice. — Regards Ohlbe |
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avinash ★ India, 2022-07-06 12:35 (820 d 08:33 ago) @ Ohlbe Posting: # 23110 Views: 2,154 |
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Dear Ohlbe Thank you. Regards, Avinash |
Ing. Helmut Schütz